Extended Follow-up of Patients With Macular Edema Due to Retinal Vein Occlusion (RETAIN)

• ClinicalTrials.gov Identifier: NCT01198327
• Recruitment Status: Completed
• First Posted: September 10, 2010
• Results First Posted: January 13, 2014
• Last Update Posted: January 13, 2014
• Sponsor: Peter A Campochiaro, MD
• Collaborators: The Macula Foundation, Inc.; Genentech, Inc.
• Information provided by (Responsible Party): Peter A Campochiaro, MD, Johns Hopkins University

Study Description

Brief Summary:

This study evaluates long-term safety in patients with macular edema due to Retinal Vein Occlusion (RVO) originally enrolled in the BRAVO & CRUISE trials and subsequently followed in the HORIZON extension trial.

Condition or disease	Intervention/treatment	Phase
Retinal Vein Occlusion	Drug: ranibizumab; Other: Peripheral Laser	Phase 3

Detailed Description:

There is strong evidence that ranibizumab provides benefit in subjects with macular edema due to RVO; however, some subjects required continued injections for years to maintain those benefits. It is likely that such subjects have continued production of VEGF (Vascular Endothelial Growth Factor) from areas of nonperfused retina in the periphery. One strategy is to perform scatter photocoagulation to areas of nonperfusion to reduce continued production of VEGF, but it is important to know if visual benefits are maintained when this is done, because if it is not, it would be better to continue intermittent injections of ranibizumab.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 66 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Extended Follow-up of Patients With Macular Edema Due to bRanch rETinal Vein Occlusion (BRVO) or centrAl Retinal veIn occlusioN (CRVO) Previously Treated With Intravitreal Ranibizumab
• Study Start Date: August 2010
• Actual Primary Completion Date: December 2012
• Actual Study Completion Date: December 2012

Arms and Interventions

Arm	Intervention/treatment
Experimental: Ranibizumab as needed; Intravitreal ranibizumab, .5mg dose, PRN but not less than 21 days apart; with optional peripheral laser to areas of non-perfusion.	Drug: ranibizumab; Intravitreal ranibizumab, .5mg dose, PRN but not less than 21 days apart.; Other Name: RBZ, lucentis; Other: Peripheral Laser; Areas of nonperfusion identified on wide field angiograms will receive laser, if the patient is continuing to require ranibizumab injections.; Other Name: Laser

Outcome Measures

Primary Outcome Measures :

1. Incidence of Serious Adverse Events. [ Time Frame: 24 mos ]
   Record the serious adverse events, both ocular and non-ocular to gather long-term safety data.

Secondary Outcome Measures :

1. Mean Changes in Visual Acuity [ Time Frame: 24 mos from study baseline ]
   Mean changes in visual acuity. Visual acuity is measured using standard ETDRS (Early Treatment Diabetic Retinopathy Study) charts which measure visual acuity in terms of letters( ETDRS Letters) read at a distance of 4 meters away from the chart. The ETDRS letters Score can be from 0 to 100, with 0 representing poor vision and 100 representing best vision.
2. Mean Change in Retinal Thickness [ Time Frame: 24 mos from study baseline ]
   Mean change in retinal thickness as measured by OCT (Optical Coherence Tomography).

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Signed informed consent and authorization of use and disclosure of protected health information
• Age greater than or equal to 18 years
• Completion of 12 months in BRAVO or CRUISE trials, with subsequent follow-up in the HORIZON extension study. Exit from HORIZON should be within 90 days of enrollment

Exclusion Criteria:

• Pregnancy (positive pregnancy test) or lactation
• Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch.
• Any condition that the investigator believes would pose a significant hazard to the subject if investigational therapy were initiated.
• Inability to comply with study or follow up procedures
• Participation in another simultaneous medical investigation or trial

Contacts and Locations

Locations

United States, California

Retina-Vitreous Associates Medical Group

Beverly Hills, California, United States, 90211

Retinal Consultants Medical Group

Sacremento, California, United States, 95819

United States, Georgia

Southeast Retina

Augusta,, Georgia, United States, 30909

United States, Massachusetts

Ophthalmic consultants of Boston

Boston, Massachusetts, United States, 02114-2587

United States, New Jersey

Retina Associates of New Jersey

Teaneck, New Jersey, United States, 07666

United States, Texas

Retina Consultants of Houston

Houston, Texas, United States, 77030

Sponsors and Collaborators

Peter A Campochiaro, MD

The Macula Foundation, Inc.

Genentech, Inc.

Investigators

• Principal Investigator: Peter A Campochiaro, MD; Johns Hopkins University

More Information

Publications:

Campochiaro PA, Hafiz G, Channa R, Shah SM, Nguyen QD, Ying H, Do DV, Zimmer-Galler I, Solomon SD, Sung JU, Syed B. Antagonism of vascular endothelial growth factor for macular edema caused by retinal vein occlusions: two-year outcomes. Ophthalmology. 2010 Dec;117(12):2387-2394.e1-5. doi: 10.1016/j.ophtha.2010.03.060. Epub 2010 Jul 13.

Campochiaro PA, Heier JS, Feiner L, Gray S, Saroj N, Rundle AC, Murahashi WY, Rubio RG; BRAVO Investigators. Ranibizumab for macular edema following branch retinal vein occlusion: six-month primary end point results of a phase III study. Ophthalmology. 2010 Jun;117(6):1102-1112.e1. doi: 10.1016/j.ophtha.2010.02.021. Epub 2010 Apr 15.

• Responsible Party: Peter A Campochiaro, MD, Principal Investigator, Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT01198327
• Other Study ID Numbers: NA_00040287
• First Posted: September 10, 2010
• Results First Posted: January 13, 2014
• Last Update Posted: January 13, 2014
• Last Verified: November 2013

Keywords provided by Peter A Campochiaro, MD, Johns Hopkins University:

RVO; CRVO; BRVO; Horizon; Bravo; Cruise

Additional relevant MeSH terms:

Macular Edema; Retinal Vein Occlusion; Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Ranibizumab; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Physiological Effects of Drugs; Growth Inhibitors; Antineoplastic Agents